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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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11 to 20 of 22 Results
productcode LOM PMA Number p Decision Date From 1/1/2007 Decision Date To 1/1/2008
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Device
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PMA
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VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PAC... Ortho-Clinical Diagnostics, In P000044 S015 03/27/2007
ELECSYS ANTI-HBS IMMUNOASSAY AND ELECSYS PRECICONT... ROCHE DIAGNOSTICS CORP. P010054 S001 03/13/2007
ELECSYS ANTI-HBS IMMUNOASSAY AND ELECSYS PRECICONT... ROCHE DIAGNOSTICS CORP. P010054 S003 03/13/2007
ROCHE ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CON... ROCHE DIAGNOSTICS CORP. P990012 S001 03/13/2007
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAG... Ortho-Clinical Diagnostics, In P030026 S012 03/05/2007
ABBOTT AXSYM HBSAG ASSAY ABBOTT LABORATORIES INC P050049 S001 02/05/2007
AXSYM AUSAB ABBOTT LABORATORIES INC P060003 S003 02/05/2007
AXSYM CORE-M 2.0 & AXSYM CORE-M 2.0 CONTROLS ABBOTT LABORATORIES INC P060009 S001 02/05/2007
AXSYM CORE 2.0 & AXSYM CORE 2.0 CONTROLS ABBOTT LABORATORIES INC P060012 S001 02/05/2007
DIASORIN ETI-AB-EBK PLUS DIASORIN, INC. P990041 S009 01/19/2007
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